MAUDE Adverse Event Report: STRYKER ENDOSCOPY-SAN JOSE PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR; INSUFFLATOR, LAPAROSCOPIC

Catalog Number 0620040610

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Emphysema (1832); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

Alleged failure: patient admitted to icu post operatively with significant subcutaneous emphysema confirmed failure: valve failure depot repair notes also stated that unit was overdue for calibration and the software was not current.Probable root cause: pressure sensor malfunction / out of calibration, software malfunction, use error, system design, unwanted movement of internal components / wiring, insufflator operated at least-favorable environmental conditions for an extended period of time.Pressure button does not disengage.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.(b)(4).

Event Description

It was reported that the patient was admitted to icu post operatively with significant subcutaneous emphysema.The procedure was completed successfully.

Manufacturer Narrative

Alleged failure: patient admitted to icu post operatively with significant subcutaneous emphysema confirmed failure: valve failure.Depot repair notes also stated that unit was overdue for calibration and the software was not current.Probable root cause: pressure sensor malfunction / out of calibration.Software malfunction.Use error.System design.Unwanted movement of internal components / wiring.Insufflator operated at least-favorable environmental conditions for an extended period of time.Pressure button does not disengage.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.

Event Description

It was reported that the patient was admitted to icu post operatively with significant subcutaneous emphysema.The procedure was completed successfully.

• Brand Name: PKG; PNEUMO SURE XL HIGH FLOW INSUFFLATOR
• Type of Device: INSUFFLATOR, LAPAROSCOPIC
• Manufacturer (Section D): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer (Section G): STRYKER ENDOSCOPY-SAN JOSE; 5900 optical court; san jose CA 95138
• Manufacturer Contact: melissa dela cruz ; 5900 optical court; san jose, CA 95138 ; 4087542000
• MDR Report Key: 6513225
• MDR Text Key: 73415324
• Report Number: 0002936485-2017-00393
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K063367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0620040610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: 03/27/2017
• Supplement Dates FDA Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other